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Evaluation of Efficacy of Online Real-time Home CPR Training Program

Primary Purpose

Cardiopulmonary Resuscitation, Cardiopulmonary Arrest, Education

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Real-time home CPR training
Conventional CPR training
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiopulmonary Resuscitation focused on measuring Cardiopulmonary Resuscitation, Education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults without prior CPR training within 6 months

Exclusion Criteria:

  • Healthcare providers

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Real-time home CPR training

Conventional CPR training

Arm Description

Online real-time home CPR(cardiopulmonary resuscitation) training will be provided to participants

Conventional CPR training will be provided to participants

Outcomes

Primary Outcome Measures

Average compression depth
Average compression depth of chest compression performed for 2 minutes

Secondary Outcome Measures

Proportion of adequate compression depth
Proportion of adequate compression depth performed for 2 minutes
Average compression rate
Average compression rate of chest compression performed for 2 minutes
Proportion of adequate compression rate
Proportion of adequate compression rate performed for 2 minutes
No-flow fraction
Proportion of no-flow time during 2 minutes of chest compression

Full Information

First Posted
August 6, 2021
Last Updated
October 24, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05023616
Brief Title
Evaluation of Efficacy of Online Real-time Home CPR Training Program
Official Title
Evaluation of Efficacy of Online Real-time Home CPR Training Program : a Randomized Open-label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. The intervention group will participate in the real-time home CPR training program while the control group will participate in the conventional CPR training program. The investigators will compare the quality of chest compression between the two study groups. The investigators hypothesize that the new real-time home CPR training program is non-inferior to the preexisting conventional CPR training program.
Detailed Description
Bystander CPR(cardiopulmonary resuscitation) is important for the survival of out-of-hospital cardiac arrest patients. CPR training for the general public is important to improve the rate and quality of bystander CPR. Conventional CPR education was conducted under face-to-face contact with instructors and multiple trainees gathered at a training center, but after the coronavirus disease 2019 pandemic, face-to-face training became difficult. To overcome this limitation the investigators have developed a new real-time home CPR training program. The training program delivers Little Anne QCPR mannequins (Laerdal, Stavanger, Norway) to each participants homes and the participants use an application specifically developed for CPR training that automatically connects wirelessly to the Little Anne QCPR mannequin through Bluetooth so that the instructor can give real-time feedback on chest compression quality to participants. The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. The intervention group will participate in the real-time home CPR training program while the control group will participate in the conventional CPR training program. The investigators will compare the quality of chest compression between the two study groups. Chest compression quality at the start of both training programs and after completion of the programs will be measured by Little Anne QCPR mannequins used in the training programs. The investigators hypothesize that the new real-time home CPR training program is non-inferior to the preexisting conventional CPR training program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Resuscitation, Cardiopulmonary Arrest, Education
Keywords
Cardiopulmonary Resuscitation, Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time home CPR training
Arm Type
Experimental
Arm Description
Online real-time home CPR(cardiopulmonary resuscitation) training will be provided to participants
Arm Title
Conventional CPR training
Arm Type
Active Comparator
Arm Description
Conventional CPR training will be provided to participants
Intervention Type
Other
Intervention Name(s)
Real-time home CPR training
Intervention Description
The participants in the intervention group will have Little Anne QCPR mannequins (Laerdal, Stavanger, Norway) delivered to their homes. The participants will use an online platform specifically developed for CPR training (HEROS Remote app). The training program will provide video-based self-instruction training followed by hands-on chest compression training with the instructor. The hands-on chest compression training session provides real-time chest compression quality measurement followed by real-time feedback from the instructor. Chest compression quality will be measured by Little Anne QCPR mannequins.
Intervention Type
Other
Intervention Name(s)
Conventional CPR training
Intervention Description
Participants in the conventional CPR training program group will be provided CPR education with the "Home Education and Resuscitation Outcome Study (HEROS)" program that is currently provided in Seoul, Korea. The HEROS program is a 1-hour training course, consisting of a 30-minute video-based self-instruction training with a mannequin. The program also includes a bystander CPR simulation with a simulated dispatcher using the participants own cell phone. Little Anne QCPR mannequins will be provided to measure and give feedback on the participants chest compression performance.
Primary Outcome Measure Information:
Title
Average compression depth
Description
Average compression depth of chest compression performed for 2 minutes
Time Frame
Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Secondary Outcome Measure Information:
Title
Proportion of adequate compression depth
Description
Proportion of adequate compression depth performed for 2 minutes
Time Frame
Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Title
Average compression rate
Description
Average compression rate of chest compression performed for 2 minutes
Time Frame
Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Title
Proportion of adequate compression rate
Description
Proportion of adequate compression rate performed for 2 minutes
Time Frame
Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Title
No-flow fraction
Description
Proportion of no-flow time during 2 minutes of chest compression
Time Frame
Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults without prior CPR training within 6 months Exclusion Criteria: Healthcare providers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Jeong Hong, MD
Organizational Affiliation
Department of Emergency Medicine, Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
STEPHEN GW LEE, MD
Organizational Affiliation
Department of Emergency Medicine, SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seulki Choi, MD
Organizational Affiliation
Department of Emergency Medicine, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33081529
Citation
Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.
Results Reference
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PubMed Identifier
32525022
Citation
Nolan JP, Monsieurs KG, Bossaert L, Bottiger BW, Greif R, Lott C, Madar J, Olasveengen TM, Roehr CC, Semeraro F, Soar J, Van de Voorde P, Zideman DA, Perkins GD; European Resuscitation Council COVID-Guideline Writing Groups. European Resuscitation Council COVID-19 guidelines executive summary. Resuscitation. 2020 Aug;153:45-55. doi: 10.1016/j.resuscitation.2020.06.001. Epub 2020 Jun 7.
Results Reference
background
PubMed Identifier
33081527
Citation
Cheng A, Magid DJ, Auerbach M, Bhanji F, Bigham BL, Blewer AL, Dainty KN, Diederich E, Lin Y, Leary M, Mahgoub M, Mancini ME, Navarro K, Donoghue A. Part 6: Resuscitation Education Science: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S551-S579. doi: 10.1161/CIR.0000000000000903. Epub 2020 Oct 21. No abstract available.
Results Reference
background
PubMed Identifier
31734702
Citation
Nas J, Thannhauser J, Vart P, van Geuns RJ, Muijsers HEC, Mol JQ, Aarts GWA, Konijnenberg LSF, Gommans DHF, Ahoud-Schoenmakers SGAM, Vos JL, van Royen N, Bonnes JL, Brouwer MA. Effect of Face-to-Face vs Virtual Reality Training on Cardiopulmonary Resuscitation Quality: A Randomized Clinical Trial. JAMA Cardiol. 2020 Mar 1;5(3):328-335. doi: 10.1001/jamacardio.2019.4992.
Results Reference
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PubMed Identifier
32604135
Citation
Park GJ, Kong SYJ, Song KJ, Shin SD, Kim TH, Ro YS, Myklebust H, Birkenes TS. The Effectiveness of a New Dispatcher-Assisted Basic Life Support Training Program on Quality in Cardiopulmonary Resuscitation Performance During Training and Willingness to Perform Bystander Cardiopulmonary Resuscitation: A Cluster Randomized Controlled Study. Simul Healthc. 2020 Oct;15(5):318-325. doi: 10.1097/SIH.0000000000000435.
Results Reference
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Evaluation of Efficacy of Online Real-time Home CPR Training Program

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